Psyllium-containing produces with a distribution of particle size

ABSTRACT

Psyllium husk comprising particle sizes distributed such that: less than about 15% is larger than about 80 mesh, at least about 45% is within the range of from about 80 mesh to about 200 mesh, and less than about 40% is smaller than about 200 mesh. In addition, psyllium-containing products for oral administration comprising small particle size psyllium husk according to the present invention are described.

This is a continuation of Ser. No. 252,848, filed Oct. 3, 1988, nowabandoned.

BACKGROUND OF THE INVENTION

The present invention relates psyllium husk of a certain small particlesize distribution; and to products containing such particle sizepsyllium husk suitable for oral administration, especially products tobe mixed in liquids to form psyllium-containing drinks.

Products containing psyllium seed husk are known (e.g., Metamucil®, soldby the Procter & Gamble Company). Such products are useful for thebenefits of normalizing bowel function and laxation. In addition, recentresearch has demonstrated the effectiveness of psyllium seed husk fiberin reducing human serum cholesterol levels, and in controlling bloodglucose levels in diabetics. See, for example, J. W. Anderson, et al.,Fed. Proc., 46, 877 (1987); J. W. Anderson, et al., Am. J.Gastroenterol., 81, 907-919 (1986); and S. Faberberg, Curr. Ther. Res.,31, 166 (1982); all incorporated herein by reference in their entirety.

The palatability of psyllium-containing products vary depending on theform used, and, of course, the user's particular preference. Frequently,however, psyllium-containing products are viewed as having poorpalatability. In particular, psyllium-containing products to be mixedwith a liquid to form a drink are considered by many to be aestheticallyobjectionable for one or more of several reasons such as texture (e.g.,grittiness, general mouth feel), viscosity, visual appearance, etc.

Therefore, improving the palatability of psyllium-containing products isa continuing need which would benefit a significant number of consumers.More palatable products may result in improved compliance for dosingregimens involving several doses or extended duration therapy. Thus,while psyllium can be (and in fact has been) combined with many carriersand flavorants in many forms, there continues to be a need for improved,highly palatable psyllium-containing products.

Current psyllium-containing products, such as products to be mixed witha liquid to form a drink, utilize subsequently more of larger particlesize psyllium husk. It has been discovered by the present invention thatby selecting a particular range of substantially smaller particle sizepsyllium, the aesthetics of psyllium-containing products are improveddramatically. In addition, in view of a large body of literature thatstates or intimates that reducing the particle size of other fibermaterials (such as wheat bran) reduces the fiber's efficacy [e.g., See:Dietary Fiber in Health and Disease, pages 10-11 (Vahouny andKritchevsky, editors; Plenum Press, New York, N.Y.; 1982); CRC Handbookof Dietary Fiber in Human Nutrition, pages 267-269 (Spiller, editor; CRCPress, Inc.; Boca Raton, Fla.; 1986); Handbook of Dietary Fiber, AnApplied Approach, pages 152-153 (Dreher; Marcel Dekker, Inc., New York,N.Y.; 1987); Kirwan et al., British Medical Journal, 4, pages 187-189(1974); Brodribb et al., Gut, 19, pages 60-63 (1978); and Cummings etal., CMA Journal, 123 , pages 1109-1114 (1980)], the present inventionis even more surprising since the psyllium of the present invention isessentially at least as efficacious as the substantially larger particlesize psyllium used previously.

It is therefore an object of the present invention to provide psylliumhusk and psyllium-containing products for oral administration havingimproved aesthetics. It is a further object to provide psyllium husk andpsyllium-containing products to be mixed with a liquid to form a drinkwhich are efficacious and have improved aesthetics, including texture,mouth feel, palatability, grittiness, and/or visual appearance.

These and other objects of the present invention will become readilyapparent from the detailed description which follows.

All percentages and ratios used herein are by weight unless otherwisespecified.

SUMMARY OF THE INVENTION

The present invention relates to psyllium husk comprising particle sizesdistributed as follows: less than about 15% larger than about 80 mesh,at least about 45% within the range of form about 80 mesh to about 200mesh, and less than about 40% smaller than about 200 mesh.

The present invention further relates to psyllium-containing productsfor oral administration comprising: (a) from about 1% to about 90% ofpsyllium husk having particle size distributions according to thepresent invention; and (b) from about 1% to about 99% carrier materialsuitable for oral administration to a human. Preferred arepsyllium-containing products containing psyllium having at least 95%purity. Also preferred are psyllium-containing products in a formsuitable for mixing with a liquid to form a drink, especially suchproducts wherein the psyllium is agglomerated.

The present invention also relates to methods for providing laxationcomprising orally administering to a human in need of laxation a safeand effective amount of psyllium having particle size distribution asdescribed herein.

DETAILED DESCRIPTION OF THE INVENTION 1. Psyllium Husk of LimitedParticle Size

The present invention relates to certain small particle size psylliumhusk from psyllium seed, from plants of the Plantago genus. Variousspecies such as Plantago lanceolate, P. rugelii, and P. major are known.Commercial psyllium husk include the French (black; Plantago indica),Spanish (P. psyllium) and Indian (blonde; P. ovata). Indian (blonde)psyllium husk is preferred for use herein. Also preferred is psylliumhusk which is at least about 95% pure, more preferably more than about95% pure, and most preferably at least about 97% pure.

Psyllium husk of the present invention comprises particle sizesdistributed as follows: less than about 15% larger than about 80 mesh,at least about 45% within the range of from about 80 mesh to about 200mesh, and less than about 40% smaller than about 200 mesh. Preferred areparticle size distribution of: less than about 10% larger than about 80mesh, at least about 65% within the range of from about 80 mesh to about200 mesh, and less than about 25% smaller than about 200 mesh. Morepreferred are particle size distribution of: less than about 5% largerthan about 80 mesh, at least about 75% within the range of from about 80mesh to about 200 mesh, and less than about 20% smaller than about 200mesh.

It is also preferred that the psyllium husk further comprise less thanabout 5% of particle sizes larger than about 60 mesh, and mostpreferably essentially no particle sizes larger than about 60 mesh. Alsopreferred is less than about 5% larger than about 80 mesh, and mostpreferred is essentially no particle sizes larger than about 80 mesh andless than about 25% larger than 100 mesh. Particle sizes and particlesize distributions may be readily determined by one of ordinary skill inthe art, for example by sieving using an Alpine Laboratory Air JetSieve, Type 200 LS (sold by Alpine American Corp., Natick Mass.).

The psyllium husk is obtained from the seed coat of psyllium seed. It istypical to remove the seed coat from the rest of the seed by, forexample, slight mechanical pressure, and then to use only the seed coat.The seed coat is preferably removed and sanitized by methods known inthe art (e.g., ethylene oxide) prior to reducing the particle size tothat described herein. Methods for reducing psyllium particle size tothose of the present invention are known in the art, or preferably maybe reduced by the use of a stud mill (also known as "pin mills") underconditions which selectively reduce the psyllium husk size relative tonon-husk impurity, thereby allowing for further purification if sodesired.

2. Psyllium-containing Products

The present invention also relates to psyllium-containing products.These products comprise psyllium husk having particle sizes distributedaccording to the present invention, and one or more carrier materialssuitable for oral administration to a human. Preferably, these productscomprise from about 1% to about 99% psyllium husk, and from about 1% toabout 99% carrier material; and more preferably from about 10% to about98% psyllium husk and from about 2% to about 90% carrier material.

The carrier materials useful for the products of the present inventionmust be safe for oral administration to humans, and may be chosen by oneof ordinary skill in the art as appropriate for the form and useintended for the product. Psyllium-containing product forms, methods formaking, and carrier materials useful for these products, are describedmore fully, for example, in U.S. Pat. No. 4,459,280, to Colliopoulos etal., issued Jul. 10, 1984; U.S. Pat. No. 4,548,806, to Colliopoulos etal., issued Oct. 22, 1985; and U.S. Pat. No. 4,321,263, to Powell etall, issued Mar. 23, 1982; all of which are incorporated by referenceherein in their entirety.

Most preferred are products of the present invention in dry powder formsuitable for mixing in a liquid (typically water) to form apsyllium-containing drink. Preferred carrier materials for such powderforms are known and are described in detail, for example, in U.S. Pat.Nos. 4,459,280 and 4,548,806, incorporated hereinbefore by reference.Preferred are such powders (preferably sugar free) comprisingmaltodextrin. Also especially preferred are powders comprisingagglomerates of psyllium and/or coated psyllium, especially agglomeratedwith maltodextrin and/or sucrose.

Psyllium-containing powders suitable for mixing in a liquid comprisingfrom about 10% to about 98% of psyllium husk having particle sizesdistributed according to the present invention (more preferably fromabout 20% to about 95% psyllium husk), and from about 0% to about 60%maltodextrin (more preferably from about 2% to about 50% maltodextrin)are preferred. Psyllium-containing products according to the presentinvention containing sugar (e.g., sucrose) comprise from about 10% toabout 60% (preferably from about 20% to about 55%) psyllium husk, fromabout 35% to about 90% sugar, and from about 0% to about 5%maltodextrin. Sugar free products typically comprise from about 40% toabout 98% (preferably from about 50% to about 95%) of psyllium huskaccording to the present invention, and from about 1% to about 60%(preferably from about 2% to about 50%) of maltodextrin. Preferredcompositions comprise agglomerated psyllium, and also preferred arecompositions wherein the carrier material comprises citric acid.

3. Methods for Providing Laxation

The present invention also relates to methods for providing laxation toa human in need of such treatment. These methods comprise administeringto a human in need of such treatment a safe and effective amount ofpsyllium having particle sizes distributed according to the presentinvention, preferably in a psyllium-containing product of the presentinvention (e.g., a psyllium-containing drink).

Ingestion of from about 1 gram to about 30 grams per day of the psylliumhusk according to the present invention is appropriate in mostcircumstances to produce laxation. However, this can vary with the sizeand condition of the patient, and such matters will, of course, be up tothe attending physician. However, since the psyllium material isnon-toxic, even higher ingestion levels can be used without undue sideeffects. A typical dose for laxation purposes involves administeringfrom about 2.5 to about 15 grams of psyllium husk in one dose.

The following examples further describe and demonstrate embodimentswithin the scope of the present invention. These examples are givensolely for the purpose of illustration and are not to be construed aslimitations of the present invention, as many variations thereof arepossible without departing from the spirit and scope.

EXAMPLE 1

Raw blond psyllium husk [95% purity; ethylene oxide sanitized; particlesize distribution approximately: on 20 mesh (841 microns)=4.6%, thru 20on 40 mesh (420 microns)=62.6%, thru 40 on 60 mesh (250 microns)=23.1%,thru 60 on 100 mesh (149 microns)=7.2%, thru 100 on 140 mesh (105microns)=1.4%, thru 140 on 200 mesh (74 microns)=0.7%, thru 200 mesh(<74 microns) =0.4% ] is selectively comminuted by using an Alpine PinMill (Model No. 160 UPZ; flow rate=70 kg/hr; full pin density; 18,000rpms; sold by Alpine American Corp., Natick, Mass.) to maximize thethrough 80 mesh on 200 mesh fraction. The comminuted psyllium huskobtained has approximately the following particle size distribution: on80 mesh (>177 microns)=15%; thru 80 on 100 mesh (177-149 microns)=2.5%;thru 100 on 120 mesh (149-125 microns)=14.2%; thru 120 on 140 mesh(125-105 microns)=14.9%; thru 140 on 170 mesh (105-95 microns)=17.7%;thru 170 on 200 mesh (95-74 microns)=16.0%; thru 200 on 325 mesh (74-44microns) =11.2%; and thru 325 mesh (<44 microns)=8.5%.

The selectively comminuted psyllium husk is purified by sifting over a60 mesh screen to sieve out much of the dark material, and then sievedto collect thru 80 on 200 mesh particle size psyllium husk according tothe present invention. This psyllium is then used to prepare thefollowing sugared product prepared by dry mixing the ingredients in aHobart mixer (Model No. N-50).

    ______________________________________                                        Ingredient      Percent of Formula                                            ______________________________________                                        Sucrose         63.43                                                         Citric Acid     2.54                                                          Orange Flavor   1.59                                                          Psyllium        32.35                                                         FD&C Yellow No. 6                                                                             0.10                                                          ______________________________________                                    

One tablespoon of this product is dispersed in 8 oz. of water to producea drink containing approximately 5.1 grams of psyllium. Consumption ofthis drink by a human is effective for providing laxation benefits.

EXAMPLE 2

Utilizing psyllium husk milled as described in Example 1 collected thru80 mesh, the following sugar free product is prepared.

    ______________________________________                                        Ingredient      Percent of Formula                                            ______________________________________                                        Psyllium        75.80                                                         Maltrin         5.50                                                          Citric Acid     11.50                                                         Potassium Citrate                                                                             1.14                                                          Aspartame       1.16                                                          Flavor          4.80                                                          FD&C Yellow No. 5                                                                             0.067                                                         FD&C Yellow No. 6                                                                             0.048                                                         ______________________________________                                    

The composition is prepared by dry mixing the ingredients lessapproximately 3% of the maltrin, and then agglomerating with theremainder of the maltrin (aqueous solution) in a top spray, fluid bedagglomerater. One teaspoon of this product is dispersed in 8 ounces ofwater to product a drink containing approximately 3.4 grams of psyllium.Consumption of this drink by a human is effective for providing laxationbenefits.

What is claimed:
 1. Psyllium husk comprising particle sizes distributedas follows: less than about 5% larger than about 60 mesh, less thanabout 15% larger than about 80 mesh, at least about 45% within the rangeof from about 80 mesh to about 200 mesh, and less than about 40% smallerthan about 200 mesh.
 2. A method for providing laxatin to a humancomprising administering to a human in need of such treatment a safe andeffective amount for laxation of psyllium husk having particle sizesdistributed according to claim
 1. 3. Psyllium husk according to claim 1comprising less than about 5% of particle sizes larger than about 80mesh.
 4. A method for providing laxation to a human comprisingadministering to a human in need of such treatment a safe and effectiveamount for laxation of psyllium husk having particle sizes distributedaccording to claim
 3. 5. A psyllium-containing drink mix compositioncomprising:(a) from about 10% to about 99% psyllium husk having aparticle size distribution according to claim 1; (b) from about 1% toabout 90% of carrier material selected from the group consisting ofsugar, maltodextrin, citric acid, flavoring agents, coloring agents, andcombinations thereof;and wherein further said composition is in a formdispersible in an aqueous liquid.
 6. A psyllium-containing drink mixcomposition according to claim 5 comprising from about 1% to about 60%maltodextrin.
 7. A psyllium-containing drink mix composition accordingto claim 6 comprising maltodextrin coated psyllium husk.
 8. Apsyllium-containing drink mix composition according to claim 5comprising from about 35% to about 90% sugar.
 9. A psyllium-containingproduct for oral administration comprising:(a) from about 1% to about99% of psyllium husks having particle size distribution of less thanabout 5% larger than about 60 mesh, less than about 15% larger thanabout 80 mesh, at least about 45% within the range of from about 80 meshto about 200 mesh, and less than about 40% smaller than about 200 mesh;and (b) from about 1% to about 99% carrier materials suitable for oraladministration to a human.
 10. The psyllium-containing product accordingto claim 9 when the psyllium husk is at least about 95% pure.
 11. Thepsyllium-containing product according to claim 9 wherein the particlesize distribution of the psyllium comprises no particles larger thanabout 80 mesh.
 12. The psyllium-containing product according to claim 11wherein the psyllium husk is at least about 95% pure.
 13. Thepsyllium-containing product according to claim 9 in a powder formwherein the carrier materials are selected from the group consisting ofdrink mix carrier materials.
 14. The psyllium-containing productaccording to claim 13 comprising coated psyllium.
 15. A method forproviding laxation to a human comprising administering to a human inneed of such treatment a safe and effective amount for laxation of apsyllium-containing product according to claim
 14. 16. Thepsyllium-containing product according to claim 13 wherein the carriermaterials comprise material selected from the group consisting ofsucrose, maltodextrin, citric acid, and combinations thereof.
 17. Amethod for providing laxation to a human comprising administering to ahuman in need of such treatment a safe and effective amount for laxationof a psyllium-containing product according to claim
 9. 18. Apsyllium-containing drink mix product comprising:(a) from about 10% toabout 60% psyllium husk having particle size distribution of less thanabout 5% larger than about 60 mesh, less than about 15% larger thanabout 80 mesh, at least about 45% within the range of from about 80 meshto about 200 mesh, and less than about 40% smaller than about 200 mesh;(b) from about 35% to about 90% sugar; and (c) from about 0% to about 5%maltodextrin.
 19. The psyllium-containing product according to claim 18wherein the psyllium is agglomerated with materials which provide fordispersion of the psyllium husk in an aqueous liquid.
 20. Apsyllium-containing drink mix product comprising:(a) from about 40% toabout 98% psyllium husk having particle size distribution of less thanabout 5% larger than about 60 mesh, less than about 15% larger thanabout 80 mesh, at least about 45% within the range of form about 80 meshto about 200 mesh, and less than about 40% smaller than about 200 mesh;and (b) from about 1% to about 60% of maltodextrin.
 21. Thepsyllium-containing product according to claim 20 wherein the psylliumis agglomerated with materials which provide for dispersion of thepsyllium husk in an aqueous liquid.
 22. Psyllium husk comprisingparticle sizes distributed as follows: no particles larger than about 80mesh; at least about 45% within the range of from about 80 mesh to about200 mesh; and less than about 40% smaller than about 200 mesh.
 23. Amethod for providing laxation to a human comprising administering to ahuman in need of such treatment a safe and effective amount for laxationof psyllium husk having particle sizes distributed according to claim22.
 24. A psyllium-containing drink mix product comprising:(a) fromabout 10% to about 98% of psyllium husk having particle sizedistribution of no particles no larger than about 80 mesh, at leastabout 45% within the range of from about 80 mesh to about 200 mesh, andless than about 40% smaller than about 200 mesh; and (b) from about 2%to about 90% carrier materials suitable for oral administration to ahuman, and wherein further said carrier materials comprise materialsselected from the group consisting of sugar, maltodextrin, citric acid,aspartame, flavoring agent, coloring agent, and combinations thereof.25. The psyllium-containing drink mix product according to claim 24comprising from about 10% to about 60% psyllium husk and from about 35%to about 90% sugar.
 26. A method for providing laxation to a humancomprising administering to a human in need of such treatment a safe andeffective amount for laxation of an aqueous dispersion of apsyllium-containing product according to claim
 25. 27. Thepsyllium-containing drink mix product according to claim 24 comprisingfrom about 40% to about 98% psyllium husk and from about 1% to about 60%of maltodextrin.
 28. A method for providing laxation to a humancomprising administering to a human in need of such treatment a safe andeffective amount for laxation of an aqueous dispersion of apsyllium-containing product according to claim
 27. 29. A method forproviding laxation to a human comprising administering to a human inneed of such treatment a safe and effective amount for laxation, of anaqueous dispersion of psyllium-containing product according to claim 24.30. An aqueous liquid dispersion of psyllium husk comprising psylliumhusks having a particle size distribution according to claim 22.